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Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fed Conditions

Information source: Par Pharmaceutical, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: To Determine Bioequivalence Under Fed Conditions.

Intervention: doxycycline monohydrate (Drug); doxycycline monohydrate (Drug); doxycycline monohydrate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Par Pharmaceutical, Inc.

Official(s) and/or principal investigator(s):
Eric Masson, Pharm D., Principal Investigator, Affiliation: Anapharm

Summary

The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen doxycycline monohydrate 100 mg.

Clinical Details

Official title: Randomized, 3-Way Crossover, Comparative Bioequivalence Study of Par Pharmaceutical Inc. (USA) and Oclassen Pharmaceuticals Inc. (USA)(Monodox(R)) Doxycycline Monohydrate Equivalent to 100 mg Doxycycline Administered as a Single Dose of 100 mg In Healthy Adult Males Under Fasting and Fed Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Bioequivalence

Detailed description: To compare the single-dose bioequivalence of Par and Oclassen (Monodox(R)), 100 mg doxycycline under fed and fasting conditions.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Males, non-smokers, between 18-55 years of age

- Subjects' weight will be within 15% of their ideal weight based on the Table of

"Desirable Weight of Adults", Metropolitan Life Insurance Company, 1983.

- Subjects should read, sign, and date an Informed Consent Form prior to any study

procedures

- Subjects must complete all screening procedures within 28 days prior to the

administration of the study medication. Exclusion Criteria:

- Clinically significant abnormalities found during medical screening

- Any clinically significant history of ongoing gastrointestinal problems or problems

known to interfere with the absorption, distribution, metabolism or excretion of drugs (e. g. chronic diarrhea, inflammatory bowel diseases).

- Clinically significant illnesses within 4 weeks of the administration of study

medication.

- Abnormal laboratory test judged clinically significant.

- ECG or vital signs abnormalities (clinically significant).

- History of allergic reactions to doxycycline or other related drugs (e. g.,

chlortetracycline, demeclocycline, minocycline and tetracycline).

- History of allergic reactions to heparin.

- Any food allergies, intolerances, restrictions, or special diet which in the opinion

of the medical sub-investigator, contraindicates the subject's participation in this study.

- Positive urine drug screen (see section VIII) at screening

- Positive testing for hepatitis B, hepatitis C or HIV screening.

- Use of an investigational drug or participation in an investigational study, within

30 days prior to administration of the study medication.

- Recent donation of plasma (500 mL) within 7 days or recent donation or significant

loss of whole blood (450 mL) with 56 days prior to administration of the study medication.

- History of significant alcohol abuse within six months of the screening visit or any

indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%)

- Recent history of drug abuse or use of illegal drugs: use of soft drugs (such as

marijuana, pot) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP), crack) within 1 year of the screening visit.

- Subjects who have taken prescription medication 14 days preceding administration of

study medication or over the counter products 7 days preceding administration of study medication, except for topical products without systemic absorption.

- Subjects who have taken any drugs known to induce or inhibit hepatic drug metabolism

within 30 days prior to administration of the study medication (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine).

- Subjects who have undergone clinically significant surgery 4 weeks prior to the

administration of the study medication.

- Any reason which, in the opinion of the medical sub-investigator, would prevent the

subject from participating in the study.

Locations and Contacts

Anapharm Inc., Sainte-Foy, Quebec, Canada
Additional Information

Starting date: November 1999
Last updated: June 22, 2011

Page last updated: August 23, 2015

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